Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Chronic Disease

Treatments: Behavioral: PREPARE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02072941

P0061026

R-1306-01500 (Other Grant/Funding Number)

Details and patient eligibility

About

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.

Full description

PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.

Enrollment: 445 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spanish-speaking adults ≥ 55 years of age
• ≥ 2 chronic illnesses determined by ICD-9 codes
• ≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
• ≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Exclusion criteria

• Deaf, blind, demented or psychotic as determined by ICD-9 codes
• Too mentally or physically ill to participate as determined by their clinicians
• Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
• Self-reported poor vision and inability to see the words on a newspaper
• Lack of a telephone (for follow-up)
• Traveling or moving out of the area for ≥3 months during the study follow-up period.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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445 participants in 2 patient groups

PREPARE intervention

Experimental group

Description:

The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.

Treatment:

Behavioral: PREPARE Intervention

Control

No Intervention group

Description:

The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.